A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray

VivaVision Biotech

Status and phase: Enrolling; Phase 1

Conditions: Chronic Rhinosinusitis (CRS)

Treatments: Drug: 1% VVN432 Nasal Spray; Drug: 0.5% VVN432 Nasal Spray; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT07259538

VVN432-CCS-101

Details and patient eligibility

About

The goal of this clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VVN432 Nasal Spray in healthy volunteers (Phase Ia) and in patients with chronic rhinosinusitis (Phase 1b).

This study consists of two parts (Phase 1a and Phase 1b):

Phase 1a (SAD) is a single-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, and PK of VVN432 Nasal Spray in healthy adult subjects.

Phase 1b (MAD) is a multi-center, randomized, double-masked, vehicle-controlled study to assess the safety, tolerability, PK/PD, and preliminary efficacy of VVN432 Nasal Spray in patients with chronic rhinosinusitis.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part 1:

• Healthy male or female subjects aged 18 to 55 years old (inclusive);
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.5 to 28.0 kg/m2 (inclusive);
• No clinically significant abnormalities at screening or baseline.

Part 2:

• Male or female patients aged 18 to 55 years old (inclusive);
• Clinically confirmed diagnosis of chronic rhinosinusitis with or without nasal polyps;
• Presence of the following symptoms for >4 weeks before screening: nasal obstruction, mucous or mucopurulent rhinorrhea, facial pain/pressure, and reduced or lost sense of smell;
• Modified Lund-Kennedy (MLK) score ≥ 2 in each nostril by nasal endoscopy;
• Lund-Mackay score (LMK) ≥ 2 in each nostril by CT scan;
• Nasal Construction Score (NCS) ≥ 2.

Exclusion criteria

Part 1:

• Known hypersensitivity or contraindications to the study drug or its components;
• History or current conditions that affect the safety or absorption of the investigational drug;
• History of drug abuse or drug dependence;
• Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer;
• If female, is pregnant or lactating, or intends to become pregnant during the study period.

Part 2:

• Known hypersensitivity or contraindications to the study drug or its components;
• Use of prohibited medications prior to screening and during the course of the study; History of drug abuse or drug dependence;
• Participation in any other clinical trials and receiving an investigational drug within 12 weeks before screening or 5 half-lives, whichever is longer;
• If female, is pregnant or lactating, or intends to become pregnant during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 8 patient groups, including a placebo group

Part 1: 0.5% VVN432 Nasal Spray (1 spray/nostril)

Experimental group

Description:

0.5% VVN432 Nasal Spray, single dose, 1 spray/nostril

Treatment:

Drug: 0.5% VVN432 Nasal Spray

Part 1: 1% VVN432 Nasal Spray (1 spray/nostril)

Experimental group

Description:

1% VVN432 Nasal Spray, single dose, 1 spray/nostril

Treatment:

Drug: 1% VVN432 Nasal Spray

Part 1: 1% VVN432 Nasal Spray (2 spray/nostril)

Experimental group

Description:

1% VVN432 Nasal Spray, single dose, 2 sprays/nostril

Treatment:

Drug: 1% VVN432 Nasal Spray

Part 1: Vehicle

Placebo Comparator group

Description:

VVN432 Nasal Spray Placebo, single dose, 1 or 2 sprays/nostril

Treatment:

Drug: Vehicle

Part 2: 0.5% VVN432 Nasal Spray (1 spray/nostril)

Experimental group

Description:

0.5% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days

Treatment:

Drug: 0.5% VVN432 Nasal Spray

Part 2: 1% VVN432 Nasal Spray (1 spray/nostril)

Experimental group

Description:

1% VVN432 Nasal Spray, BID, 1 spray/nostril, for 28 days

Treatment:

Drug: 1% VVN432 Nasal Spray

Part 2: 1% VVN432 Nasal Spray (2 sprays/nostril)

Experimental group

Description:

1% VVN432 Nasal Spray, BID, 2 sprays/nostril, for 28 days

Treatment:

Drug: 1% VVN432 Nasal Spray

Part 2: Vehicle

Placebo Comparator group

Description:

VVN432 Nasal Spray Placebo, BID, 1 or 2 sprays/nostril, for 28 days

Treatment:

Drug: Vehicle